Actively Recruiting
Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
Led by Cyprus University of Technology · Updated on 2022-09-02
60
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
C
Cyprus University of Technology
Lead Sponsor
G
German Oncology Center, Cyprus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multimodal education and support program aimed at preventing cancer-related cachexia syndrome in patients undergoing anti-cancer treatments and their family caregivers. The study focuses on patients with solid tumors such as stomach, colorectal, pancreas, breast, and lung cancer, during treatments like chemotherapy, immunotherapy, hormone therapy, or target therapy. The research is led by Cyprus University of Technology and involves a randomized, triple-blind design. Participants will be randomly assigned to either the intervention or control group for a 12-week program. The intervention group receives four meetings with a cancer nurse and clinical dietician, each about 30 minutes long, covering education on diet and symptom management related to cancer treatment. Both groups undergo blood tests measuring CRP and albumin levels, body composition assessments, and complete questionnaires at these sessions. During the study, patients and their caregivers will be monitored at baseline and at weeks 4, 8, and 12 through blood tests, body measurements, and quality of life questionnaires. Researchers will measure changes in pre-cachexia status, inflammation, edema, and quality of life for both patients and caregivers. This comprehensive monitoring aims to assess the program's impact on preventing cachexia and supporting patient well-being throughout the treatment period.
CONDITIONS
Brief Title
Multimodal Program for Cancer Related Cachexia Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
- Needing chemotherapy, immunotherapy, hormone therapy, or target therapy
- Normal or pre-cachectic as defined by guidelines
- Able to read and understand Greek or English
- Must nominate a family caregiver
You will not qualify if you...
- Diagnosed with haematologic tumors
- Receiving parenteral nutrition
- ECOG Performance status greater than 2 or Karnofsky Performance Status less than 60%
- Unable to introduce a family caregiver
- In cachexia or refractory cachexia stage as defined by guidelines including weight loss over 5% in 6 months, BMI below 20 with weight loss over 2%, or sarcopenia with weight loss over 2%
- Using complementary therapies such as acupuncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants undergo a 12-week multimodal program including 4 meetings with a cancer nurse and clinical dietician. During these meetings, participants have blood tests, body composition measurements, questionnaires, and education on diet and symptom management related to cancer treatment.
4 visits (in-person, about 30 minutes each)
Trial Site Locations
Total: 1 location
1
German Oncology Centre
Limassol, Cyprus, 4065
Actively Recruiting
Research Team
A
Andreas Charalambous, PhD
C
Constantina Cloconi, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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